CN101530401A - Compound transdermal patch used for curing acute and chronic inflammatory pain - Google Patents
Compound transdermal patch used for curing acute and chronic inflammatory pain Download PDFInfo
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- CN101530401A CN101530401A CN200810026841A CN200810026841A CN101530401A CN 101530401 A CN101530401 A CN 101530401A CN 200810026841 A CN200810026841 A CN 200810026841A CN 200810026841 A CN200810026841 A CN 200810026841A CN 101530401 A CN101530401 A CN 101530401A
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- sensitive adhesive
- pressure sensitive
- percutaneous plaster
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- diclofenac
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Abstract
The invention discloses a compound transdermal patch used for curing acute and chronic inflammatory pain. The patch comprises a compound penetrating agent and a pressure sensitive adhesive and is characterized by also comprising Xylocaine or hydrochloride thereof and sodium salt or sylvite of diclofenac. The transdermal patch contains the following components by weight percentages: 1-20 percent of Xylocaine or the hydrochloride thereof, 1-20 percent of the sodium salt or sylvite of diclofenac, 1-30 percent of compound penetrating agent and 40-49 percent of pressure sensitive adhesive. Aiming at overcoming the defects of the existing medicinal preparations in treatment and use, the invention provides a compound transdermal patch that is used for curing acute and chronic inflammatory pain, can act on local human body and quickly permeate, and is good in treatment effect, safe and convenient in use.
Description
Technical field
The present invention relates to a kind of compound transdermal patch that is used for the treatment of acute and chronic inflammatory pain, more particularly, the present invention relates to a kind of compound lidocaine percutaneous plaster of the treatment acute and chronic inflammatory pain by two principal agent composition lignocaine or its hydrochlorate and diclofenac sodium or potassium salt use in conjunction.
Background technology
Acute and chronic pain is common a kind of disease, at present, treat various acute and chronic pain mainly based on oral nonsteroidal anti-inflammatory drug treatment, but oral nonsteroidal anti-inflammatory drug has serious stimulation to gastrointestinal tract, and curative effect is short, DeGrain, some local pains particularly, it is low that oral drugs arrive local pain fraction medicine concentration, thereby make DeGrain, so need be provided at the local novel form preparation that produces fine therapeutic effect.
Transdermal drug delivery system is meant in the skin surface administration, makes medicine see through skin with constant or approaching constant speed, enters the novel form that human circulation produces whole body or local therapeutic effects.Transdermal drug delivery system is a non-invasive administration new way, is the 4th generation pharmaceutical preparation developmental research focus.Its advantage is: can avoid the first pass effect of liver and medicine to degrade at gastrointestinal, fully improve bioavailability; Keep stable and persistent blood drug level, reduce the toxicity and the side effect of medicine; Reduce administration number of times, and avoid pain on injection, easy to use, interruption of the administration at any time, patient compliance is good.
Summary of the invention
The objective of the invention is for overcome existing pharmaceutical preparation treatment and use in weak point, provide a kind of can effect and body local, can rapid osmotic, the compound transdermal patch that therapeutic effect is good and safe.
In order to achieve the above object, the present invention adopts following scheme:
A kind of compound transdermal patch that is used for the treatment of acute and chronic inflammatory pain comprises compound penetrating agent, pressure sensitive adhesive, it is characterized in that: it also includes lignocaine or its hydrochlorate and its sodium salt of diclofenac or its potassium salt.
Aforesaid percutaneous plaster, it comprises following components in weight percentage:
Lignocaine or its hydrochlorate 1-20%
Its sodium salt of diclofenac or its potassium salt 1-20%
Compound penetrating agent 1-30%
Pressure sensitive adhesive 40-90%
Aforesaid percutaneous plaster, it also includes release-controlled film, and described release-controlled film is selected from ethylene-vinyl acetate copolymer (EVA) film, polychloroethylene film, polyethylene film or microporous polypropylene membrane.
Aforesaid percutaneous plaster, wherein said release-controlled film are ethylene-vinyl acetate copolymer (EVA) films.
Aforesaid percutaneous plaster, wherein said lignocaine or its hydrochlorate are lignocaine.
Aforesaid percutaneous plaster, wherein said lignocaine or its hydrochlorate are lidocaine hydrochloride.
Aforesaid percutaneous plaster, its sodium salt of wherein said diclofenac or its potassium salt are diclofenac sodium.
Aforesaid percutaneous plaster, its sodium salt of wherein said diclofenac or its potassium salt are diclofenac potassium.
Aforesaid percutaneous plaster, wherein compound penetrating agent are selected from a kind of or multiple arbitrarily in ethanol, propylene glycol, fatty acid ester, dimethyl sulfoxide ex hoc genus anne thing, oleic acid, linoleic acid, lauryl alcohol, azone and homologue thereof, sodium lauryl sulphate, Tween 80, carbamide, salicylic acid, pyrrolidinone compounds, menthol, Camphora, limonene, the eucalyptole.
Aforesaid percutaneous plaster, wherein compound penetration enhancer is propylene glycol, lauryl alcohol, azone and menthol.
Aforesaid percutaneous plaster, wherein pressure sensitive adhesive is selected from acrylics pressure sensitive adhesive, polyisobutylene class pressure sensitive adhesive or silicone pressure sensitive adhesive.
Aforesaid percutaneous plaster, wherein pressure sensitive adhesive is hydrophilic acrylate's class pressure sensitive adhesive.
Aforesaid arbitrary percutaneous plaster, the pain that wherein said percutaneous plaster is used for various active chronic inflammations and causes.
Aforesaid percutaneous plaster, wherein the scope of its treatment pain comprises the pain that following disease causes, the inflammation of muscle, joint, joint capsule, synovial capsule, tendon, stndon sheath and lumbar spine, the pain that rheumatism causes outside joint degeneration and the joint.The present invention is used for the treatment of various active chronic inflammations and causes pain, and its pharmacodynamic index of optimizing prescription sees Table 1, table 2.
The test of table 1 mouse writhing number of times (x ± sd)
Annotate: compare with the blank group, * represents p＜0.05; * represents p＜0.01
Table 1 is the result show: positive controls and blank group are relatively turned round the body number of times and are significantly reduced, and statistical significance (p＜0.05) is arranged, and the establishment of this pilot system is described.What compound transdermal patch of the present invention and blank group more all can reduce mice turns round the body number of times, turns round the body number of times and significantly is lower than the blank group, and statistical significance (p＜0.05-0.01) is arranged.Under this experiment condition, compound transdermal patch of the present invention has significant analgesic activity.
Table 2 on Carrageenan causes the influence (x ± sd) of rat paw edema
Annotate: compare with model control group, * represents p＜0.05, and * * represents p＜0.01
Table 2 is the result show: positive controls 3h, 6h swelling rate after causing inflammation all are starkly lower than model control group, and its difference has statistical significance (p＜0.05-0.01), show the establishment of this experimental system.Paster of the present invention all significantly is lower than model control group (p＜0.01) apart from the swelling rate causing scorching back 3h foot, all significantly is lower than model control group (p＜0.05-0.01) apart from the swelling rate causing scorching back 6h foot.Under this experiment condition, paster of the present invention has the obvious suppression effect to swelling.
Above-mentioned two tests show that compound transdermal patch of the present invention has obvious anti-inflammatory and analgesic effect.
In sum, advantage of the present invention is as follows:
1, the compound penetrating agent of the present invention's employing, can make two principal agent composition lignocaine and diclofenac sodium be dissolved in the water-soluble pressuree-sentitive adhesive effectively, form a kind of solid dispersion transparent sheet, increased stability of drug, increased Transdermal absorption greatly, use also very convenient and safety, can effectively control various acute and chronic inflammatory pains.
2, the present invention adopts the hydrophilic macromolecule pressure sensitive adhesive, and is safe and non-stimulating, can to human body anaphylaxis, irritant reaction do not arranged and peels off easily on human body as traditional rubber-like pressure sensitive adhesive etc.
3, the present invention has used compound penetrating agent, compound penetrating agents such as azone and lauryl alcohol, azone and Mentholum and sodium lauryl sulphate, change skin texture by reversibility and penetrate into skin, increase Transdermal absorption, reduce the transdermal resistance of lignocaine and diclofenac sodium, reach the purpose that promotes absorption of medicine whole body or topical therapeutic.
4, the present invention has used compound penetrating agent to increase lignocaine and the dissolubility of diclofenac sodium in carrier.
5, percutaneous plaster of the present invention can permeate by rapid transdermal, and therapeutic effect is good.Diclofenac sodium is a phenyl acetic acid derivatives, has analgesia, antiinflammatory, antipyretic effect, and its analgesic activity is stronger than aspirin and indomethacin, being about 26～50 times of aspirin, is periphery type analgesic, and characteristics are strong drug action, untoward reaction is light, and dosage is little, and individual variation is little.Lignocaine is widely used local anesthetics of amide derivatives, with the diclofenac sodium synergism, analgesic activity is preferably arranged in this prescription.And make the transdermal administration dosage form, drug withdrawal at any time avoids the same with other NSAID (non-steroidal anti-inflammatory drug) as oral formulations, and untoward reaction such as gastrointestinal tract infringement and headache, dizziness are arranged, and percutaneous plaster of the present invention is very easy to use.
The specific embodiment
The present invention will be further described below in conjunction with embodiment:
Embodiment 1
Compound transdermal patch of the present invention includes the following component of mass percent: 1% lignocaine, 15% diclofenac sodium, 8% compound penetrating agent and 76% hydrophilic macromolecule pressure sensitive adhesive.
Preparation method wherein of the present invention is as follows:
Compound penetrating agent with 8%, 1% lignocaine and 15% diclofenac sodium mix, wherein to adopt concentration be 2% azone to the compound penetrating agent of present embodiment and concentration is 3% lauryl alcohol and 3% ethanol, above-mentioned substance is ground even, ultrasonic dissolution, add hydrophilic acrylate's copolymer emulsion of 76% again, stir, the ultrasonic degas bubble is coated on the separate paper, dry, cover polyethylene film, cutting packs and promptly obtains compound transdermal patch of the present invention.
Embodiment 2
Compound transdermal patch of the present invention includes the following component of mass percent: 20% lidocaine hydrochloride, 5% diclofenac sodium, 20% compound penetrating agent and 55% hydrophilic macromolecule pressure sensitive adhesive.
Preparation method wherein of the present invention is as follows:
Compound penetrating agent with 20%, 20% lidocaine hydrochloride and 5% diclofenac sodium mix, wherein the compound penetrating agent of present embodiment adopts the mixture of azone, propylene glycol, oleic acid and menthol, above-mentioned substance is ground evenly, and ultrasonic dissolution adds 55% pressure sensitive adhesive matrix hydrophilic acrylate copolymer emulsion again, grind evenly, de-bubbled is coated on the separate paper drying, cutting, packing promptly obtains compound transdermal patch of the present invention.
Embodiment 3
Compound transdermal patch of the present invention includes the following component of mass percent: 10% lignocaine, 20% diclofenac potassium, 10% compound penetrating agent and 60% hydrophilic macromolecule pressure sensitive adhesive.
Preparation method wherein of the present invention is as follows:
Compound penetrating agent with 10%, 10% lignocaine and 20% diclofenac potassium mix, wherein the compound penetrating agent of present embodiment adopts the mixture of fat ethyl acetate, azone, Tween 80, lauryl alcohol, above-mentioned substance is ground evenly, and ultrasonic dissolution adds 60% pressure sensitive adhesive matrix hydrophilic acrylate copolymer emulsion again, grind evenly, de-bubbled is coated on the separate paper drying, cutting, packing promptly obtains compound transdermal patch of the present invention.
Embodiment 4
Compound transdermal patch of the present invention includes the following component of mass percent: 15% lignocaine, 7% diclofenac sodium, 15% compound penetrating agent and 63% Polyisobutylene PSA.
Preparation method wherein of the present invention is as follows:
Compound penetrating agent with 15%, 7% lignocaine and 15% diclofenac sodium mix, wherein the compound penetrating agent of present embodiment adopts the mixture of propylene glycol, lauryl alcohol, azone and menthol, above-mentioned substance is ground evenly, and ultrasonic dissolution adds 63% Polyisobutylene PSA substrate again, grind evenly, de-bubbled is coated on the separate paper drying, cutting, packing promptly obtains compound transdermal patch of the present invention.
Embodiment 5
Compound transdermal patch of the present invention includes the following component of mass percent: 15% lidocaine hydrochloride, 15% diclofenac potassium, 10% compound penetrating agent and 60% Polyisobutylene PSA.
Preparation method wherein of the present invention is as follows:
The diclofenac potassium of the compound penetrating agent with 10%, 15% L-Caine E 5% mixes, wherein the compound penetrating agent of present embodiment adopts propylene glycol, azone and oleic mixture, above-mentioned substance is ground evenly, and ultrasonic dissolution adds 60% Polyisobutylene PSA substrate again, grind evenly, de-bubbled is coated on the separate paper drying, cutting, packing promptly obtains compound transdermal patch of the present invention.
Embodiment 6
Compound transdermal patch of the present invention includes the following component of mass percent: 20% lignocaine, 20% diclofenac sodium, 5% compound penetrating agent, 45% hydrophilic macromolecule pressure sensitive adhesive and 10% release-controlled film.
Preparation method wherein of the present invention is as follows:
Compound penetrating agent with 5%, 20% lignocaine and 20% diclofenac sodium mix, wherein the compound penetrating agent of present embodiment adopts the mixture of lauryl alcohol, Tween 80, menthol, limonene, above-mentioned substance is ground evenly, ultrasonic dissolution, the pressure sensitive adhesive matrix hydrophilic high mol ACR emulsion that adds 10% release-controlled film and 45% again, release-controlled film is ethylene-vinyl acetate copolymer (EVA) in the present embodiment, above-mentioned substance is ground evenly, de-bubbled, coat on the separate paper, drying, cutting, packing promptly obtains compound transdermal patch of the present invention.
Claims (14)
1, a kind of compound transdermal patch that is used for the treatment of acute and chronic inflammatory pain comprises compound penetrating agent, pressure sensitive adhesive, it is characterized in that: it also includes lignocaine or its hydrochlorate and its sodium salt of diclofenac or its potassium salt.
2, percutaneous plaster according to claim 1, it comprises following components in weight percentage:
Lignocaine or its hydrochlorate 1-20%
Its sodium salt of diclofenac or its potassium salt 1-20%
Compound penetrating agent 1-30%
Pressure sensitive adhesive 40-90%
3, percutaneous plaster according to claim 1 and 2, it also includes release-controlled film, and described release-controlled film is selected from ethylene-vinyl acetate copolymer (EVA) film, polychloroethylene film, polyethylene film or microporous polypropylene membrane.
4, percutaneous plaster according to claim 3, wherein said release-controlled film are ethylene-vinyl acetate copolymer (EVA) films.
5, percutaneous plaster according to claim 1, wherein said lignocaine or its hydrochlorate are lignocaine.
6, percutaneous plaster according to claim 1, wherein said lignocaine or its hydrochlorate are lidocaine hydrochloride.
7, percutaneous plaster according to claim 1, its sodium salt of wherein said diclofenac or its potassium salt are diclofenac sodium.
8, percutaneous plaster according to claim 1, its sodium salt of wherein said diclofenac or its potassium salt are diclofenac potassium.
9, percutaneous plaster according to claim 1, wherein compound penetrating agent are selected from a kind of or multiple arbitrarily in ethanol, propylene glycol, fatty acid ester, dimethyl sulfoxide ex hoc genus anne thing, oleic acid, linoleic acid, lauryl alcohol, azone and homologue thereof, sodium lauryl sulphate, Tween 80, carbamide, salicylic acid, pyrrolidinone compounds, menthol, Camphora, limonene, the eucalyptole.
10, require 9 described percutaneous plasters according to the cane profit, wherein compound penetrating agent is propylene glycol, lauryl alcohol, azone and menthol.
11, percutaneous plaster according to claim 1, wherein pressure sensitive adhesive is selected from acrylics pressure sensitive adhesive, polyisobutylene class pressure sensitive adhesive or silicone pressure sensitive adhesive.
12, percutaneous plaster according to claim 11, wherein pressure sensitive adhesive is a hydrophilic acrylics pressure sensitive adhesive.
13, according to the described arbitrary percutaneous plaster of claim 1-12, the pain that wherein said percutaneous plaster is used for various active chronic inflammations and causes.
14, percutaneous plaster according to claim 13, wherein it treats the scope of pain, comprise the pain that following disease causes, the inflammation of muscle, joint, joint capsule, synovial capsule, tendon, stndon sheath and lumbar spine, the pain that rheumatism causes outside joint degeneration and the joint.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810026841A CN101530401A (en) | 2008-03-12 | 2008-03-12 | Compound transdermal patch used for curing acute and chronic inflammatory pain |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810026841A CN101530401A (en) | 2008-03-12 | 2008-03-12 | Compound transdermal patch used for curing acute and chronic inflammatory pain |
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| CN101530401A true CN101530401A (en) | 2009-09-16 |
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| CN200810026841A Pending CN101530401A (en) | 2008-03-12 | 2008-03-12 | Compound transdermal patch used for curing acute and chronic inflammatory pain |
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Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102716487A (en) * | 2011-03-29 | 2012-10-10 | 兰州大学 | Permeation enhancer for improving transdermal absorption of Ginsenoside-Rd and application thereof |
| CN102791267A (en) * | 2010-01-07 | 2012-11-21 | 帝国制药株式会社 | Anti-inflammatory analgesic adhesive patch for external use |
| CN103608009A (en) * | 2011-06-20 | 2014-02-26 | 久光制药株式会社 | Lidocaine-containing cataplasm |
| CN105708823A (en) * | 2016-04-08 | 2016-06-29 | 中国药科大学 | Long-acting diclofenac transdermal patch and preparation technology thereof |
| CN107669661A (en) * | 2016-12-12 | 2018-02-09 | 青岛大学 | Diclofenac sodium transdermal patch |
| CN108024979A (en) * | 2015-08-24 | 2018-05-11 | 伊藤忠富隆达化工株式会社 | Non-aqueous patch comprising lidocaine |
| CN110638832A (en) * | 2019-11-07 | 2020-01-03 | 蚌埠丰原医药科技发展有限公司 | Nano-silver lidocaine antibacterial pain-relieving plaster and preparation method thereof |
| JP2020505416A (en) * | 2017-01-31 | 2020-02-20 | 帝國製薬株式会社 | Pharmaceutical patch containing lidocaine and diclofenac for treating neuropathic pain |
| JP2020505422A (en) * | 2017-01-31 | 2020-02-20 | 帝國製薬株式会社 | Dosage regimen for medicated patches containing lidocaine and diclofenac |
| WO2022007917A1 (en) * | 2020-07-10 | 2022-01-13 | 江苏恒瑞医药股份有限公司 | Transdermal preparation containing anesthetic drug active ingredient and preparation method therefor |
| US11872320B2 (en) | 2021-02-25 | 2024-01-16 | Hisamitsu Pharmaceutical Co., Inc. | Method for treating osteoarthritis |
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2008
- 2008-03-12 CN CN200810026841A patent/CN101530401A/en active Pending
Cited By (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102791267A (en) * | 2010-01-07 | 2012-11-21 | 帝国制药株式会社 | Anti-inflammatory analgesic adhesive patch for external use |
| US8657798B2 (en) | 2010-01-07 | 2014-02-25 | Teikoku Seiyaku Co., Ltd. | Anti-inflammatory analgesic adhesive patch for external use |
| CN102791267B (en) * | 2010-01-07 | 2015-06-10 | 帝国制药株式会社 | Anti-inflammatory analgesic adhesive patch for external use |
| CN102716487A (en) * | 2011-03-29 | 2012-10-10 | 兰州大学 | Permeation enhancer for improving transdermal absorption of Ginsenoside-Rd and application thereof |
| CN103608009A (en) * | 2011-06-20 | 2014-02-26 | 久光制药株式会社 | Lidocaine-containing cataplasm |
| CN103608009B (en) * | 2011-06-20 | 2015-04-29 | 久光制药株式会社 | Lidocaine-containing cataplasm |
| CN108024979A (en) * | 2015-08-24 | 2018-05-11 | 伊藤忠富隆达化工株式会社 | Non-aqueous patch comprising lidocaine |
| CN105708823A (en) * | 2016-04-08 | 2016-06-29 | 中国药科大学 | Long-acting diclofenac transdermal patch and preparation technology thereof |
| CN107669661A (en) * | 2016-12-12 | 2018-02-09 | 青岛大学 | Diclofenac sodium transdermal patch |
| CN107669661B (en) * | 2016-12-12 | 2020-05-26 | 山东朱氏药业集团有限公司 | Diclofenac sodium transdermal patch |
| JP2020505416A (en) * | 2017-01-31 | 2020-02-20 | 帝國製薬株式会社 | Pharmaceutical patch containing lidocaine and diclofenac for treating neuropathic pain |
| JP2020505422A (en) * | 2017-01-31 | 2020-02-20 | 帝國製薬株式会社 | Dosage regimen for medicated patches containing lidocaine and diclofenac |
| JP7109092B2 (en) | 2017-01-31 | 2022-07-29 | 帝國製薬株式会社 | Pharmaceutical patch for the treatment of neuropathic pain containing lidocaine and diclofenac |
| JP7109093B2 (en) | 2017-01-31 | 2022-07-29 | 帝國製薬株式会社 | Dosing Regimens for Pharmaceutical Patches Containing Lidocaine and Diclofenac |
| CN110638832A (en) * | 2019-11-07 | 2020-01-03 | 蚌埠丰原医药科技发展有限公司 | Nano-silver lidocaine antibacterial pain-relieving plaster and preparation method thereof |
| WO2022007917A1 (en) * | 2020-07-10 | 2022-01-13 | 江苏恒瑞医药股份有限公司 | Transdermal preparation containing anesthetic drug active ingredient and preparation method therefor |
| US11872320B2 (en) | 2021-02-25 | 2024-01-16 | Hisamitsu Pharmaceutical Co., Inc. | Method for treating osteoarthritis |
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Open date: 20090916 |